Interventional Neuroradiology Reflections on 30 years UKNG 50

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Interventional Neuroradiology Reflections on 30 years UKNG 50 th Anniversary Meeting Andrew J Molyneux

Interventional Neuroradiology Reflections on 30 years UKNG 50 th Anniversary Meeting Andrew J Molyneux Oxford Neurovascular and Neuroradiology Research Unit, Nuffield Department of Surgical Sciences University of Oxford

Interventional Neuroradiology From experiment to practice n First use of latex detachable balloons to

Interventional Neuroradiology From experiment to practice n First use of latex detachable balloons to occlude intracranial vessels and aneurysms by Serbinenko & Schegolov in Russia published in Journal of Neurosurgery in 1974 n Gerard De-Brun from Paris brought technology to the West in about 1975 – 1976. n 1977 - 1978 Use in Cambridge and Oxford for treatment of direct C- C fistulas: Desmond Hawkins and Philip Sheldon n BK in London

Interventional Neuroradiology What’s Changed? �Everything’s changed ; � Technology the equipment � Techniques �

Interventional Neuroradiology What’s Changed? �Everything’s changed ; � Technology the equipment � Techniques � Capabilities Range of diseases treated � Personnel � Organisation � Pressure � Expectation � External Environment

What’s Changed? Nothing’s changed: �Patients and diseases �Quality and resilience of the Staff

What’s Changed? Nothing’s changed: �Patients and diseases �Quality and resilience of the Staff

How do we Introduce new devices and technology into Neuro. Radiology ? �Regulatory Pathway

How do we Introduce new devices and technology into Neuro. Radiology ? �Regulatory Pathway – Drugs �Phase 1 – 2 Trials, Safety - Efficacy �Phase 3 RCT �Market approval �UK NICE for Cost effectiveness / Benefit �Regulatory Pathway for Devices: � Introduced in the 1990’s �CE Marking – Substantially equivalent to existing approved device � 510 K for FDA �Need to show safety and some evidence of efficacy in phase 1 & 2 Trials � No requirement for clinical effectiveness studies � No requirement in Europe for an RCT

The Key figures in the Development of Detachable balloons �Scheglov & Serbinenko Russia and

The Key figures in the Development of Detachable balloons �Scheglov & Serbinenko Russia and Ukraine 1970’s �Gerard De. Brun Paris, London Ontario, Chicago �Latex detachable balloons �Grant Hieshima, San Francisco �Detachable silicone balloons �Chuck Kerber, San Diego – �Calibrated leak balloon – for delivery of glue to AVM’s �Leopold Plowecki �BALT extrusion – Pursil tubing for intracranial catheterisation 1980 -1981. �Jacques Moret , Paris

Who’s Who in Interventional Neuroradiology

Who’s Who in Interventional Neuroradiology

Original Detachable Debrun Latex Balloons Attaching the balloon and securing with Latex Thread

Original Detachable Debrun Latex Balloons Attaching the balloon and securing with Latex Thread

The Development and use of Detachable balloons �C-C and other fistulas �Parent Artery occlusion

The Development and use of Detachable balloons �C-C and other fistulas �Parent Artery occlusion �From about 1978 to 1990’s �e. g. giant cavernous / ICA

�Initial supply of balloon devices from Ingenor: �Debrun detachable balloons: 1976 – 1980’s Latex

�Initial supply of balloon devices from Ingenor: �Debrun detachable balloons: 1976 – 1980’s Latex tied on. �Microcatheters – BALT – �Pursil tubing – for Magic type catheters for glue embolisation. � 1980 – 1983. �Gold valve latex balloons �Hieshima: �Developed by Interventional Therapeutics (Bill & Julie). �Silicone detachable balloons filled with polymer – HEMA. �Treated a small number of aneurysms with DSB. Risk of aneurysm rupture ! acute and delayed

Treating Carotid cavernous fistula with Latex detachable balloons n TE born 1944 n. Presented

Treating Carotid cavernous fistula with Latex detachable balloons n TE born 1944 n. Presented in 1962 at age 18 fell from his motor scooter and sustained a skull base fracture and traumatic CCF. n 1962 – 1972 n. Common Carotid ligation n. Internal Carotid Ligation n. Craniotomy and Intracranial ICA ligation n Represented 1982

TE at presentation in 1982

TE at presentation in 1982

Vertebral angio 1982

Vertebral angio 1982

Operative placement of Left ICA sheath

Operative placement of Left ICA sheath

Post treatment with Debrun latex balloons & IBCA

Post treatment with Debrun latex balloons & IBCA

7 Days post op

7 Days post op

1 year follow up

1 year follow up

Plain Film 7 Latex balloons 1999

Plain Film 7 Latex balloons 1999

Represented 1999 �Developed posterior fossa symptoms small ischaemic event

Represented 1999 �Developed posterior fossa symptoms small ischaemic event

Presented 2003 with small posterior fossa stroke

Presented 2003 with small posterior fossa stroke

CTA 2003

CTA 2003

The Development and use of Detachable balloons in Aneurysms �Usage �Trial occlusion & Parent

The Development and use of Detachable balloons in Aneurysms �Usage �Trial occlusion & Parent Vessel occlusion and treatment of proximal aneurysms �Intra- aneurysmal use was limited, developed in Soviet Union. �Latex balloons - Jacques Moret in aneurysms – results not published – presented many times �Silicone detachable balloons – Hieshima for aneurysms and proximal vessel occlusion

Detachable Silicone Balloon in Large ICA aneurysm

Detachable Silicone Balloon in Large ICA aneurysm

Treatment of a large Basilar Aneurysm with Silicone detachable balloons

Treatment of a large Basilar Aneurysm with Silicone detachable balloons

Treatment of a large Basilar Aneurysm with Silicone detachable balloons

Treatment of a large Basilar Aneurysm with Silicone detachable balloons

The development of coils for cerebral aneurysms �Target Therapeutics – 1985 – Spin off

The development of coils for cerebral aneurysms �Target Therapeutics – 1985 – Spin off of �Advanced cardiovascular systems - ACS �Development of Tracker Catheter by Eric Engelsen �Combined with micro guide wires �Enabled safer and reliable using wire guide catheterisation of cerebral vessels. �To deliver – Particulate embolic and pushable microfibre coils �Used to treat difficult aneurysms pre GDC. �Casasco et al reported 71 patients treated with pushable coils in JNS 1993 �Small number of patients treated with pushable coils in

Various Interventionists

Various Interventionists

The development of detachable coils for cerebral aneurysms �Late 1980’s �Guido Guglielmi and Ivan

The development of detachable coils for cerebral aneurysms �Late 1980’s �Guido Guglielmi and Ivan Sepetka (Target engineer) & Fernado Vinuela at UCLA. �Developed the Guglielmi Detachable Coil (GDC) �Original idea was working on Electro thrombosis. �Found by accident that the coils detached. �First Clinical use at UCLA in early 1990 – and announced at ASNR in LA that year. �First European use – Oxford June 1992.

Development of interventional techniques Introduction of Platinum Coils Neuroradiology � 1990 First use of

Development of interventional techniques Introduction of Platinum Coils Neuroradiology � 1990 First use of a Guglielmi detachable platinum coil GDC to treatment a cerebral aneurysm at UCLA �First use in UK in Oxford June 1992

JW Aged 30 A 30 -year-old woman presented with a long history of episodic,

JW Aged 30 A 30 -year-old woman presented with a long history of episodic, severe frontal headache. At the time of admission, the headaches were daily, worse in the morning, lasted up to 10 hours, and lately had been associated with vomiting. Physical examination revealed no abnormality. Contrastenhanced cranial computed tomography and magnetic resonance revealed a giant basilar tip aneurysm. This was confirmed by vertebral angiography (Fig 1 A and B), which demonstrated rapid and rotatory flow within the aneurysm lumen.

Giant Basilar Aneurysm Treated 1993 Female aged 30 Presenting with headaches Renowden S &

Giant Basilar Aneurysm Treated 1993 Female aged 30 Presenting with headaches Renowden S & Molyneux AJNR 1995

JW Aged 30 The variable-stiffness catheter was introduced into the aneurysm, and through this

JW Aged 30 The variable-stiffness catheter was introduced into the aneurysm, and through this catheter five platinum Guglielmi detachable coils (Tracker 18, 8 -mm helix by 40 -cm length) were inserted sequentially, without complication. The detachment time for four of the coils ranged from 11 to 25 minutes, but the fifth coil had still not detached at 100 minutes. The delivery wire was torqued, and the fifth coil was successfully released. At this stage the procedure was terminated, and it was estimated that approximately 40% of the aneurysm had been occluded (Fig 1 C and D).

ONYX Liquid aneurysm treatment training 2001 Limoges

ONYX Liquid aneurysm treatment training 2001 Limoges

Technique �Onyx HD 500 �Hyperglide balloon �Rebar microcatheter �Medtronic INX Stents used in 2

Technique �Onyx HD 500 �Hyperglide balloon �Rebar microcatheter �Medtronic INX Stents used in 2 patients �All Heparinized/Aspirin and Clopridogel Graphics courtesy of The Methodist Hospital, Houston, Texas

28 year old haemophiliac with severe headaches

28 year old haemophiliac with severe headaches

MS Age 28 Haemophiliac - severe headaches

MS Age 28 Haemophiliac - severe headaches

Onyx treatment of basilar aneurysm

Onyx treatment of basilar aneurysm

Onyx treatment of basilar aneurysm Cast and balloon position

Onyx treatment of basilar aneurysm Cast and balloon position

Onyx treatment of basilar aneurysm Immediate post treatment angio

Onyx treatment of basilar aneurysm Immediate post treatment angio

Onyx treatment of basilar aneurysm 3 month Follow up angiogram

Onyx treatment of basilar aneurysm 3 month Follow up angiogram

Onyx treatment of basilar aneurysm 3 month Follow up angiogram Patient asymptomatic

Onyx treatment of basilar aneurysm 3 month Follow up angiogram Patient asymptomatic

Female 60 yrs with unsteadiness

Female 60 yrs with unsteadiness

Female 60 yrs with unsteadiness

Female 60 yrs with unsteadiness

Female 60 yrs with unsteadiness �

Female 60 yrs with unsteadiness �

Female 60 yrs with unsteadiness

Female 60 yrs with unsteadiness

Re-treatment 3 months Symptomatically significantly better

Re-treatment 3 months Symptomatically significantly better

Re-treatment 3 months with Neuroform and ONYX

Re-treatment 3 months with Neuroform and ONYX

Neuroform in place and 30 mm Hyperglide balloon

Neuroform in place and 30 mm Hyperglide balloon

Post re-treatment tent & ONYX

Post re-treatment tent & ONYX

Pre treatment Early post treatment 2 year follow up

Pre treatment Early post treatment 2 year follow up

2 year follow up Basilar Trunk aneurysm treatment Age 62 Clinically well

2 year follow up Basilar Trunk aneurysm treatment Age 62 Clinically well

ONYX treatment of Broad based ICA aneurysm 45 male with large SAH

ONYX treatment of Broad based ICA aneurysm 45 male with large SAH

ONYX treatment of Broad based ICA aneurysm 45 year old male SAH

ONYX treatment of Broad based ICA aneurysm 45 year old male SAH

Angiogram at 2 weeks

Angiogram at 2 weeks

Neuroform stent and Hyperglide balloon

Neuroform stent and Hyperglide balloon

Seal Test with Neuroform Stent & 30 mm Hyperglide balloon

Seal Test with Neuroform Stent & 30 mm Hyperglide balloon

ONYC cast after injection cycles

ONYC cast after injection cycles

Final Angiogram ONYX & Neuroform

Final Angiogram ONYX & Neuroform

ONYX Liquid Embolic system in treatment of Vascular malformations and aneurysms 4 years experience

ONYX Liquid Embolic system in treatment of Vascular malformations and aneurysms 4 years experience �Total patients treated �Brain AVM �Spinal Cord AVM �Aneurysms �Intracranial Dural AVF �Direct Carotid Cavernous fistulas �Spinal dural AVM �Meningioma 110 60 15 25 6 3 2 1

Intracranial aneurysms with ONYX Conclusions about 2004 �The morbidity and mortality associacted with treatment

Intracranial aneurysms with ONYX Conclusions about 2004 �The morbidity and mortality associacted with treatment is not different from that expected with other comlex aneurysm treatment e. g. with stents �The aneurysm occlusion rates are better than the reported results for coil treatment alone. �The use in combination with stents appears more effective in large and Giant aneurysms �The relationship of this technique to stent and coils is uncertain (esp. Matrix or Hydrogel) �This device may have a role in a small proportion of patients with difficult aneurysms

The Durability of Endovascular Coiling and Neurosurgical Clipping of Ruptured Cerebral Aneurysms. �The long-term

The Durability of Endovascular Coiling and Neurosurgical Clipping of Ruptured Cerebral Aneurysms. �The long-term risk of recurrent subarachnoid haemorrhage, dependency and death and standardised mortality ratios after coiling and clipping of a ruptured intracranial aneurysm. � 18 -year follow-up of the UK cohort of the International Subarachnoid Aneurysm Trial (ISAT) The Lancet Published on Line 28 th October 2014 Vol: 385, p 691 -697 21 st February 2015 Correspondence – 6 th June 2015 AJ Molyneux, J Birks, A Clarke, M Sneade, RSC Kerr

What is the probability of being alive at 10 years and having a favourable

What is the probability of being alive at 10 years and having a favourable Rankin score ? � 68. 2 % of UK endovascular patients in ISAT were alive and independent � 61. 7 % of the Neurosurgical patients were alive and independent. �Odds ratio: 1. 335 (95% CI 1. 085 to 1. 643) �Statistically significantly more likely to be alive and independent at 10 years after coiling allocation

What are the Causes of Death in UK Cohort? � 1644 patients enrolled �

What are the Causes of Death in UK Cohort? � 1644 patients enrolled � 16579 person years of follow-up up to 17. 6 years �A total of 389 deaths amongst the cohort � 140 patients died in the first year. � 249 patients have died during the period of follow-up period after one year � 6 died from the treated aneurysm � 4 endovascular and 2 Neurosurgery � 9 deaths due to rupture of another aneurysm � 232 have died of causes other than a SAH. � Mostly cancer and cardiovascular disease

Lancet 2015 Conclusions �Interpretation: �The 10 -year mortality was significantly greater in the neurosurgical

Lancet 2015 Conclusions �Interpretation: �The 10 -year mortality was significantly greater in the neurosurgical group. There is an increased risk of recurrent bleeding from a coiled aneurysm compared with a clipped aneurysm but the risk is small and, very importantly, the clinical benefit in respect of disability free survival in patients allocated endovascular coiling observed at one-year is maintained at 10 years.

ISAT 10 - 18 year outcomes Conclusions �Research in Context �Interpretation: � ISAT results

ISAT 10 - 18 year outcomes Conclusions �Research in Context �Interpretation: � ISAT results have changed worldwide clinical practice and the study is very unlikely to be repeated. � This paper shows that the durability of coil treatment and the clinical benefit of coiling that was observed at one year are maintained at 10 years. The risk of death and re-bleeding from the treated aneurysm, up to 18 years, in both groups is very small and similar to the risk of recurrent haemorrhage from another aneurysm. � All patients have an increased standardised mortality ratio (1. 40) compared with the general population but they are far more likely (40 times) to die as a result of causes other than the treated aneurysm; mainly cancer or cardiovascular disease. � This emphasises the importance advice about lifestyle factors, particularly smoking and control of hypertension, in these patients.

US practice in Unruptured Aneurysms treatment - AJNR 2010 �RESULTS: The fraction of unruptured

US practice in Unruptured Aneurysms treatment - AJNR 2010 �RESULTS: The fraction of unruptured aneurysms treated with coiling increased from 20% in 2001 to 63% in 2008. For surgical clipping, the percentage of patients discharged to long -term facilities was 14. 0% (4184/29, 918) compared with 4. 9% (1655/34, 125) of coiled patients (P <. 0001). Clipped patients also had a higher mortality rate because 344 (1. 2%) clipped patients died compared with 215 (0. 6%) coiled patients (P <. 0001). Between 2001 and 2008, the overall number of adverse outcomes from treatment had decreased from 14. 8% to 7. 6%.

Final Messages to young INR’s �KISS principle: Keep It Simple and Safe. Christopher Adams

Final Messages to young INR’s �KISS principle: Keep It Simple and Safe. Christopher Adams “A Neurosurgeons Handbook” �Do not pursue angiographic perfection at the risk of a higher complication rate �Simple coiling works �Do not always be seduced by the latest technology �When have a hammer everything looks like a nail �Continued follow-up of patients if 6 month F/U is OK is probably not needed �Remember the objective – �preventing re-bleeding �not a perfect picture �Treat patients – Not Angiograms or Scans !

Thanks to all the investigators who have supported the ISAT study for such a

Thanks to all the investigators who have supported the ISAT study for such a long time But especially thanks to all the patients and their relatives who agreed to participate and made all these studies possible High quality procedural Randomised trials are possible in Radiology !